Q&A: PBM Legislation “Highly Likely” to Pass This Year
Drug Topics
SEPTEMBER 19, 2024
Following the Federal Trade Commission’s interim report on PBMs, legislators are galvanized to make change happen.
Thu.Sep 19, 2024
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Long-overlooked scientist shares Lasker Award with other GLP-1 researchers
STAT
SEPTEMBER 19, 2024
GLP-1 based drugs are transforming the treatment of obesity and opening up new avenues for addressing heart disease , addiction , and even Alzheimer’s. Now, three scientists who played key roles in their invention have won a prestigious Lasker Award for biomedical research. Announced on Thursday in New York, the Lasker-DeBakey Clinical Medical Research Award will be shared by Svetlana Mojsov and Joel Habener , who identified and characterized the GLP-1 hormone in the 1980s whil
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Enhancing Patient Outcomes: The Role of Integrated Health System Specialty Pharmacies
Pharmacy Times
SEPTEMBER 19, 2024
These pharmacies address cost, understanding, and safety concerns through high-touch support and coordination.
Opinion: A failing health care system caused my husband’s death
STAT
SEPTEMBER 19, 2024
On Tuesday, the Centers for Disease Control and Prevention, the Centers for Medicare and Medicaid Services, and the Agency for Healthcare Research and Quality took an important step: They launched the Core Elements of Hospital Diagnostic Excellence , a new project to help reduce the number of Americans who die or are permanently disabled each year by diagnostic error.
From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience
Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.
The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven
Indiana insurers, hospitals accused of Medicaid fraud in giant whistleblower lawsuit
Fierce Healthcare
SEPTEMBER 19, 2024
Major Indiana managed care organizations and health systems are blamed for defrauding the state Medicaid system by tens, if not hundreds, of millions of dollars, says a newly unsealed whistleblower | A newly unsealed lawsuit alleges major health insurers and health systems defrauded Indiana Medicaid by hundreds of millions of dollars, with the government office likely influenced by corporate lobbying.
STAT+: Ginkgo Bioworks bets on protein AI model, and data generation to turn flailing company around
STAT
SEPTEMBER 19, 2024
Amid layoffs and a disintegrating share price, former investor darling Ginkgo Bioworks is trying out a new tack to find customers. The biotech this week announced a new artificial intelligence model for use in biological research, as well as a data service academic researchers and companies can use to develop their own models. The announcement comes as a growing number of biotechs, big tech companies, and academics apply neural networks and machine learning to biology, promising that the same ba
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STAT+: FDA designates devices for heart surgery, smart knee implant as ‘breakthroughs’
STAT
SEPTEMBER 19, 2024
Check out STAT’s exclusive breakthrough devices tracker. The latest medical devices to receive breakthrough status from the Food and Drug Administration range across conditions, with several treating cardio and neurovascular conditions. The FDA’s breakthrough devices program is designed to speed the path to market for novel, potentially lifesaving products.
Phase 3 Study Displays Positive Results of Co-Administration of RSV and Shingles Vaccine
Pharmacy Times
SEPTEMBER 19, 2024
Results displayed a non-inferior immune response of the co-administered vaccines, compared to administration in individual visits.
STAT+: A new cell therapy company takes its vision from four founders, and its skin from George Church
STAT
SEPTEMBER 19, 2024
Serial biotech founder George Church has a new startup, and this time, he has skin in the game, quite literally. Church, the enigmatic founder behind companies including eGenesis , Editas Medicine, and Colossal Biosciences , donated some of his own skin cells for use at his new startup GC Therapeutics. (And yes, the letters in the company’s name stand for “George Church.
Dandelion Health launches AI marketplace for model validation, use in clinical trials
Fierce Healthcare
SEPTEMBER 19, 2024
Health tech startup Dandelion Health launched a clinical artificial intelligence marketplace that merges third-party algorithms and Dandelion's data platform and model validation capabilities | Through a new solution, Dandelion Health can bring together AI developers and life sciences companies to answer questions in a fraction of the time as a randomized controlled trial.
Position Your Pharmacy for Expansion
Speaker: Chris Antypas and Josh Halladay
Access to limited distribution drugs and payer contracts are key to pharmacy expansion. But how do you prepare your operations to take the next step? Meaningful data: Collect and share clinical data regarding outcomes, utilization, and more Reporting: Limited distribution models require efficient tracking and reporting systems Workflows: Align workflows with specific pharma and payer contractual requirements For in-depth, expert insights on pharmacy expansion, watch this webinar from Inovalon.
STAT+: Corbus sees Novo’s controversial obesity approach as a ticket to a blockbuster
STAT
SEPTEMBER 19, 2024
NEW YORK — Nearly two decades ago, European regulators pulled an obesity drug called rimonabant off the market due to concerns it was tied to suicidal ideation. Now, a small handful of companies are developing drugs that use a similar approach to the discarded treatment, which involves inhibiting type 1 cannabinoid receptors, or CB1 receptors.
New migraine drugs less effective than previous generation of triptan meds: BMJ study
Fierce Pharma
SEPTEMBER 19, 2024
A study from The BMJ indicates that the newest class of migraine drugs—which includes Pfizer’s Nurtec, AbbVie’s Ubrelvy and Eli Lilly’s Reyvow—is less effective in the acute treatment of migra | A study from The BMJ indicates that the newest class of migraine drugs—which includes Pfizer’s Nurtec, AbbVie’s Ubrelvy and Eli Lilly’s Reyvow—is less effective in the acute treatment of migraines than a previous class of medicines.
STAT+: Lawmakers urge U.S. Patent Office and drug makers to correct patent mistakes
STAT
SEPTEMBER 19, 2024
A group of lawmakers wants the U.S. Patent & Trademark Office and drug companies to change their approach toward handling mistakes in disclosing patent terms, because the errors can be exploited in ways that thwart competition and, ultimately, raise the cost of medicines. The problem cited by the lawmakers concerns the way that administrative delays are handled at the PTO.
Granules India scolded over truckloads of torn manufacturing documents after recent FDA inspection
Fierce Pharma
SEPTEMBER 19, 2024
From truckloads of torn documents to avian incursions in the production plant, Granules India’s recent manufacturing reprimand from the FDA is alarming no matter which way you look at it. | Earlier this month, Granules was slapped with a Form 483 following an inspection of its Telangana facility in India that ran from Aug. 26 to Sept. 6. The FDA’s report cites six observations around poor quality control procedures, subpar cleaning, cross-contamination risks and more.
What the FDA's New Dosage Guidance Means for the Future of Clinical Research
Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist
What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.
Senate HELP Committee votes for civil, criminal charges after Steward CEO dodges subpoena
Fierce Healthcare
SEPTEMBER 19, 2024
The Senate Committee on Health, Education, Labor and Pensions voted unanimously Thursday morning to bring civil enforcement and a criminal contempt charge against Steward Health CEO Ralph de la Tor | Ralph de la Torre, M.D., invoked the Fifth Amendment in his refusal to appear before Congress. Sens. Sanders and Cassidy said that he must invoke that right in person and in response to specific questions during testimony.
SARS-CoV-2 Wastewater Presence at Highest Levels Since January as COVID-19 Cases Increase
Pharmacy Times
SEPTEMBER 19, 2024
Though hospitalizations and test positivity remain at modest levels, wastewater analysis indicates high circulation of SARS-CoV-2, especially in western states.
Talkspace offers therapy via Amazon, and 23andMe board members resign
STAT
SEPTEMBER 19, 2024
You’re reading the web edition of STAT’s Health Tech newsletter, our guide to how technology is transforming the life sciences. Sign up to get it delivered in your inbox every Tuesday and Thursday. Talkspace offers therapy through Amazon now As virtual mental health company Talkspace aims to grow its business, it’s added a very large entry point to the top of its funnel.
Expert Discusses Pharmacy Deserts, Expanding Pharmacy Access
Pharmacy Times
SEPTEMBER 19, 2024
Jenni Zilka discusses the growing issue of "pharmacy deserts" and the need to maintain the financial viability of pharmacies.
5 Reasons to Upgrade Your Pharmacy Management Software
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Are you still using workarounds to manage your daily operations? To achieve peak performance, it's time to explore other options for specialty and infusion pharmacy software. Streamline pharmacy operations and improve clinical performance with automated processing, real-time data exchange, and electronic decision support. Download this helpful infographic to: Drive efficiency and patient adherence from referral receipt to delivery and ongoing care – all with our Pharmacy Cloud.
Opinion: Medicaid must prepare to cover twice-yearly HIV prevention injection
STAT
SEPTEMBER 19, 2024
In June, a clinical trial showed that a twice-yearly injection was just as effective at preventing HIV as the daily oral medication. The trial was so successful that the Data Monitoring Committee instructed researchers to halt the study and immediately offer the injection to all study participants. This is just the most recent development in longer-acting HIV medications, which have become a transformative force in the journey toward ending the HIV/AIDS crisis.
Fam-Trastuzumab Deruxtecan Shows Positive Results for HER2-Positive Breast Cancer with Brain Metastases
Pharmacy Times
SEPTEMBER 19, 2024
Patients with for HER2-positive breast cancer have an increased risk of developing brain tumors.
STAT+: FDA cites Granules, a large Indian generic drug manufacturer, for tossing truckloads of key documents
STAT
SEPTEMBER 19, 2024
Amid ongoing concern over the quality of medicines made in India, a major supplier of generic medicines was seen removing three truckloads of “scrap materials” from a facility that was being inspected last month by the Food and Drug Administration. Specifically, a “large number of torn pieces” of documents that should have been kept to verify manufacturing and testing practices were found in the trucks, as well as in a scrap bag at a site run by Granules in Telangana,
Q&A: PCMA on Drug Pricing and the Pharmaceutical Supply Chain
Drug Topics
SEPTEMBER 19, 2024
Johnny Garcia, Senior Director of Policy at the Pharmaceutical Care Management Association, discussed ongoing issues within the pharmaceutical supply chain and his organization’s role within it.
Cannabinoids for weight loss, a cancelled ad comm, and the Fed lowers interest rates
STAT
SEPTEMBER 19, 2024
Are generalist investors good or bad for biotech? How did Elaine and Adam’s trip to New York go? And how long has George Church owned that brown corduroy blazer? We cover all that and more on the latest episode of “The Readout Loud.” Mizuho analyst Jared Holz joins us to discuss what the Federal Reserve’s long-awaited decision to lower interest rates means for biotech stocks and startups.
Liraglutide with Lifestyle Interventions Decreased BMI for Children 6 to 11
Drug Topics
SEPTEMBER 19, 2024
Compounded with lifestyle interventions, researchers compared liraglutide with a placebo to measure its efficacy amongst children under 12 years old.
STAT+: Corbus shares will soar or dive soon. Here’s why
STAT
SEPTEMBER 19, 2024
This is the online edition of Adam’s Biotech Scorecard, a subscriber-only newsletter. STAT+ subscribers can sign up here to get it delivered to their inbox. I’ve been in New York City all week attending the Cantor Global Healthcare Conference and meeting with investor sources. Big thanks to Cantor hosts Josh Schimmer and Eric Schmidt for the invite.
Neuralink gets breakthrough tag for sight-restoring implant
pharmaphorum
SEPTEMBER 19, 2024
Neuralink gets FDA breakthrough status for an implantable chip called Blindsight that promises to restore eyesight to the blind
STAT+: Senate panel votes to hold Steward Health Care CEO in contempt
STAT
SEPTEMBER 19, 2024
A Senate committee on Thursday approved referring Steward Health Care chief executive Ralph de la Torre for civil and criminal charges over his refusal to testify about the hospital chain’s financial crisis. The Senate Health, Education, Labor, and Pensions Committee voted 20 to zero, with only Kentucky Senator Rand Paul abstaining, on both resolutions to hold de la Torre in contempt of Congress after he skipped appearing at a hearing last week despite being subpoenaed.
Vanda slams FDA rejection of gastroparesis drug
pharmaphorum
SEPTEMBER 19, 2024
FDA turns down Vanda Pharma's tradipitant for gastroparesis, prompting a furious response from the company
Gilead's Kite exits China cell therapy joint venture with Fosun Pharma
Fierce Pharma
SEPTEMBER 19, 2024
Gilead Sciences’ Kite Pharma will sell its stake in China’s Fosun Kite Biotechnology nearly eight years after forming the 50-50 cell-therapy-focused joint venture with Fosun Pharma. | Gilead Sciences’ Kite Pharma will sell its stake in China’s Fosun Kite Biotechnology nearly eight years after forming the cell therapy-focused joint venture with Fosun Pharma.
ICER mulls GSK COPD drugs ahead of next Medicare negotiation
pharmaphorum
SEPTEMBER 19, 2024
ICER will preempt the next Medicare drug pricing round with a 'special report' on two COPD drugs from GSK
Top three trends in precision medicine
Pharmaceutical Technology
SEPTEMBER 19, 2024
An innovative approach to healthcare, precision medicine is a new medical model that takes into account individual differences in genes, environments, and lifestyles to drive better outcomes through medicine.
Respiratory biotech Upstream joins Nasdaq IPO surge
pharmaphorum
SEPTEMBER 19, 2024
Upstream Bio has become the latest biotech to chance its arm with a public listing in the US, seeking funds for its rival to respiratory drug Tezspire.
STAT+: Pharmalittle: We’re reading about a rare-disease drug bill, compounded Wegovy, and more
STAT
SEPTEMBER 19, 2024
Rise and shine, everyone, another busy day is on the way. However, this is shaping up as a beautiful day as well, despite forecasts suggesting a cloud or two will later hover about. Right now, the skies are tranquil, birds are chirping, and the official mascots are hunting for snacks on the Pharmalot campus. This calls for celebration with a cup of stimulation, and we are reaching for maple bourbon, a reliable stand-by.
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